Over the years, there have been many devices proposed for use in recording and associating medical information with an individual. Most commonly, this medical information includes the basic information necessary for emergency treatment such as blood type, allergic drug reactions, closest relative, any on-going medications, and other similar kinds of data. In the prior art, various kinds of fill-in-the-blank cards, tags, labels and the like are available for use. These may stored in a wallet, worn as a bracelet or necklace, associated with a shoe or other article of clothing, or otherwise associated or attached to an individual. These prior art devices have met with limited success, for various reasons.
One drawback encountered with these prior art devices is the limited amount of information which may be conveniently recorded and carried. Secondly, the information is typically recorded by the individual himself and is therefore subject to mistake and/or error due to the fact that the individual is rarely medically trained. Therefore, the medical information must first be obtained from a doctor or other trained medical personnel and errors may develop through merely communicating this information to the individual. For the same reason, not all of the more pertinent information may be recorded as it may not be known or appreciated by the individual. Similarly, updating the information occurs only haphazardly, subject to the whim of the individual. There may also be problems encountered in retrieving this information at the time of its need. The location of the data must first be ascertained, and then the data correctly read from the card or other means used to record the data. Unhappily, an individual's own handwriting may be sufficiently bad to prevent the reading of data even after location of the data card. Additionally, the data entry on the card may have been obliterated or otherwise obscured. All of these difficulties represent drawbacks in the various approaches in the prior art which have limited the widespread adoption and use of these prior art devices.
With the advance of technology, other problems and lost opportunities are increasingly experienced. The increasing sophistication of health care, in many cases relying on specialists who diagnose and treat patients upon referral from a general practitioner, develop information which is almost never routinely entered by an individual in any self kept medical data history. This specialized medical information is routinely available only in the specialist's files or records which is generally separated from that of the general practitioner. Information such as laboratory test results, specific diagnoses or prescriptions, and other related data thus becomes routinely unavailable except upon further inquiry from a knowing source. It is not believed that there is a standardized methodology for collecting all of this information in a single repository such as at the general practitioner's office.
This becomes increasingly important with the advent of science, proliferation of specialists, and increasing mobility of our civilized nations populations. Unless uncommon care is taken by an individual, his medical records are often remote from and even lost from use at the time of need. Not only is this important for routine examinations and consultations for medical problems, but increasingly so for emergency situations. This phenomenon diminishes the value of any self kept records including medical data information cards which, at most, is what emergency medical personnel may expect to find prior to administering any emergency medical treatment.
The inventors herein are also aware of a passive electrical transponder which has been used in the prior art to mark or identify inventory items and even livestock with an identifying number or code for inventory purposes. The passive electrical transponder is quite small, generally comprising a cylinder 2 mm in diameter by 11 mm in length, and its code may be conveniently read by an electromagnetic hand held reader. In operation, the hand held reader is brought into proximity of the transponder and emits a low frequency magnetic field to activate the passive transponder and thereby cause it to transmit its encoded data to the reader. With this particular commercial device, no battery or other source of electrical power is included in the passive transponder which helps contribute to its small size. One of the patents which have issued which describes these commercially available passive transponders and hand held readers is U.S. Pat. No. 5,041,826, the disclosure of which is incorporated by reference. In this patent, the patentee suggests that the primary object of the device is for identifying an object, animal or person. However, the inventors herein are not aware of any usage presently made of this device for identifying humans. Furthermore, this device is presently used to merely identify an object or the like for inventory purposes, and such application would not seem to be particularly adaptable for use with humans as much less intrusive and convenient means are already available for such purposes, including driver's licenses, and other forms of "identification".
The inventors herein are also the inventors of the combination of a passive transponder and surgically implantable implants as disclosed and claimed in one of the parent applications and patent mentioned above. This good and valuable invention provides a ready means for identifying a particular prosthesis, including details relating to its manufacturer, date of manufacture, model number, and other desired data. This invention provides a ready means for complying with the Safe Medical Devices Act of 1990 and its reporting and record keeping requirements. This information and tracking is generally performed by a medical practitioner, in many cases the same practitioner who surgically implanted the prosthesis, and the data relating thereto maintained in the medical practitioners files. There is no system or methodology for reporting and recording this data, and updating it, in a centralized data bank which could be extremely useful for statistical analysis to track failure rates or otherwise form the basis for recommended action with respect to the existing user population. Additionally, the Safe Medical Devices Act of 1990 mandates reporting and record keeping requirements for medical devices beyond those which are surgically implanted. Examples of these include infusion pumps. Currently, there are over 250 makes and models of mechanical infusion pumps to deliver nutrition, drugs, hormones, and fluids to patients. Morphine pumps are used to deliver chronic pain relief. Food infusion pumps deliver nutrients to post operative patients as well as the premature, disabled, and elderly. Drug infusion pumps are used for treatment of a wide variety of clinical disorders including Aids, hemophilia, and diabetes. Should the infusion device leak, under or over infuse, or otherwise malfunction, the patient can suffer dire consequences and even die. Ventilators are another example of devices common in hospitals, hospices, nursing homes, and home health care applications. Again, if the ventilator should malfunction, the patient could suffer dire consequences. Various kinds of monitors including pulse oximeters and apnea (CO.sub.2) monitors are devices used very commonly in hospitals and even in home care situations to monitor critical respiratory parameters. If these devices fail to properly monitor and appropriately warn, a patient could suffer dire consequences. The Tokos systems to prevent premature birth are another example of a monitoring system used in home health care. All of these various devices are subject to FDA adverse event reporting, warning notices, manufacturer recalls, etc. Identification and tracking of these devices and their use with patients has become mandatory as a result of the Safe Medical Devices Act of 1990.
The reporting requirements mandated require the owner of these various devices to keep detailed records of every patient who has ever used a particular piece of equipment. Accordingly, if an infusion pump is used in a hospital setting by 100 different patients over its useful life, the hospital must maintain these records. Proper sterilization, maintenance, and re-calibration testing records must also be scrupulously maintained. These reporting and tracking requirements represent a significant burden of administrative effort not presently funded or staffed by hospitals and will impact the cost of health care.
In a novel and unique approach, the inventors herein have succeeded in conceiving of the use of the passive transponder for direct implantation in a human with the transponder being encoded to correspond to appropriate medical information in one of several ways. In practice, the passive transponder would be encoded and would then be implanted directly into a human in a conveniently accessible location, such as under the arm in the armpit. Because of its small size, it would be unobtrusive and barely even noticeable to the patient. At the same time, the transponder could be encoded in one of several ways to provide ready and complete access to a wide variety of medical information. Furthermore, the medical information will have been verified and stored by trained medical professionals such that its accuracy can be relied upon even in emergency situations.
With presently commercially available devices, the transponder may be encoded with up to sixty-four binary bits of data. This memory size is expected to be increased as the passive transponder is further developed and improved over time. With this memory size, much information could be directly encoded and stored in the transponder itself. With at least one commercial device, there are three different ways to encode information into the transponder. The first of these is to encode the information at the time that the chip is manufactured. Ordinarily, if encoding is performed at this time, then a unique number would be encoded into the transponder and it could then be used to access data stored in a data bank, as explained more completely herein. Secondly, the memory chip may be encoded after manufacture, but prior to sealing the chip into the transponder envelope. If the chip were to be encoded at this stage, then custom encoding could be achieved which could be medical information associated with any particular patient. Thirdly, the chip could be manufactured and sealed in the transponder envelope without encoding, and perhaps even implanted in the patient. Encoding could then take place through a read/write operation with the electromagnetic reader as described herein. If encoded in this manner, custom encoding could be utilized to directly encode the transponder with medical information corresponding to the particular patient. With any of the three methods for encoding the transponder, a unique identifier may be utilized and the identifier used to access data in a remote data bank.
The encoded information contained in the passive transponder could be used to access a data bank which would be immediately available, for example over telephone lines, such that trained medical personnel could readily obtain the medical information on an emergency basis. With the remote data bank option, the amount of data which may be stored is virtually unlimited, the data bank may be updated or changed as the patient's information changed, and all of this data entry, alteration, and accessing would be handled by trained personnel in order to provide reliable medical data for the safety and benefit of the patient, as well as for reduced legal liability.
In addition to medical data relating to individual patients, data relating to medical devices and their use with patients may also be readily recorded and tracked using the transponder methodology. As noted in the parent application and patent mentioned above, transponders may be associated with surgically implantable prostheses. Data relating to these implants may be regularly collected and transmitted to a central data base which can record and track the data. Statistical analyses may be readily performed on the data at the data base in a secure manner through various methodologies and the results provided to various interested individuals and organizations with access limited by an audit or oversight commission. Furthermore, the transponder methodology may also be extended to non-implanted medical devices such as the infusion pumps, ventilators, and monitors mentioned above. Indeed, for purposes of the present invention, a medical "device" may be presumed to include any sort or manner of object, thing, or other assemblage which is related to health care. Other examples include transplanted tissue such as organs, skin, etc., heart valves, pace makers, and any other medical device, appliance, or thing which would provide usefulness to a patient over an extended period of time such as several years. Further examples include implants comprised of other mammalian tissue, cells, or composite devices such as genically engineered cells incorporated directly into an implantable device. Cornea transplants and blood vessel grafts are still further examples.
The wealth of medical data which is presently available, and its increasing amount and complexity, is creating a strain on the present medical data collection and recording systems which creates a long felt need for the present invention. One of the sad experiences of the world is the proliferation of the Aids virus for many years without detection due in large part to the lack of a centralized medical information data base through which statistical analysis could have identified this disturbing epidemic at a stage much earlier than that experienced. Societal concerns as to confidentiality can be satisfied through a "blue ribbon" international audit and oversight commission which could control access to the data base as well as the various statistical analyses which could prove highly beneficial for tracking various kinds of medical devices as well as the health condition of the many individuals who participate in the data base system of the present invention. There are many encoding schemes which are presently available so as to limit the access of any third party user who desires to access an individuals data for treatment or who wishes to update medical data for any particular patient after an examination, laboratory tests, or the like. For example, the data base could be segmented and separate look up tables provided to match particular patient i.d.'s with their individual data base entries. Any statistical analysis or other processing of the data base information could be performed without any access to the individual patient i.d. or look up table information to thereby preserve confidentiality and yet generate highly valuable statistical information relating to any data recorded in the data base. This applies both to patient information as well as medical device information. For third party users, access to the data base can be very "user friendly" such as by telecommunication over any telephone using a modem as is well known in the art. A computer or other input/output device could be used, with the proper i.d. information both to gain access to the data base as well as any individual patient records kept in the data base. Depending upon the desires of the patients, access may be as restricted or open as he desires, within limits. Furthermore, provision may be made for changing the accessibility of patient data over the life of the patient.
As is well known, there may be tremendous legal liability which could result from reliance on inaccurate data. This inaccurate data could result in any one of the many ways discussed above in connection with the prior art attempts to solve this problem. With the present invention the legal liability would be effectively minimized and could also be isolated and controlled for insurance purposes with those who are trained and skilled in handling this kind of data. With these advantages, it is expected that many medical personnel will welcome the adoption and implementation of the present invention.
While the principal advantages and features of the present invention have been described above, a more complete and thorough understanding of the invention may be attained by referring to the drawing and description of the preferred embodiment which follow.